Model Number 1012538-40 |
Device Problems
Difficult to Insert (1316); Premature Activation (1484)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/24/2022 |
Event Type
malfunction
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Manufacturer Narrative
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It is unknown if the device is returning for analysis.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The other absolute pro self-expanding stent system (sess) referenced is filed under a separate medwatch report number.
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Event Description
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It was reported that the procedure was to treat a lesion in the distal superficial femoral artery (sfa) with moderate calcification and high at target lesion and moderate tortuosity.The 10.0x100mm absolute pro self-expanding stent system (sess) was advanced to the target lesion and the stent was attempted to be deployed; however, the thumbwheel of the sess was stuck.While attempting to remove the sess, the stent flowered approximately 2cm into the sheath.The sheath was pulled back; however the stent remained in the patient in the iliac bifurcation and partially in the target lesion.Then a second 10.0 x 40mm absolute pro sess was attempted to be advanced to treat the target lesion; however, it was noted that the first stent was deployed, partially in the introducer sheath.Therefore, the 10.0x40mm absolute pro failed to be inserted into the vessel, so the device was removed from the patient and the stent deployed outside the patient.The procedure was aborted since the lesion had been previously dilated.There was a delay in procedure resulting in increased anticoagulation time as well as the inability to treat the lesion.No additional information has been provided.
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Event Description
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Subsequent to the initially filed report, the following information was received: the second absolute pro sess did not fully deploy outside the patient; although the stent did flower outside the patient.The second absolute pro sess was discarded by the facility.In addition it was reported that the patient was stable after the procedure was aborted.No additional information has been provided.
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Manufacturer Narrative
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The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that due to the first stent being stuck partially in the sheath the 10.0 x 40mm absolute pro sess failed to reach the target lesion resulting in the reported difficult to insert.Interaction/manipulation of the device resulted in the reported premature activation outside of the anatomy.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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Search Alerts/Recalls
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